Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01883258|
Recruitment Status : Recruiting
First Posted : June 21, 2013
Last Update Posted : April 5, 2018
The study objectives are:
- To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
- To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
- To examine the mechanisms underlying the exercise-related changes in cardiovascular function.
The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: High intensity aerobic interval training Other: Continuous moderate intensity exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: High intensity aerobic interval training
Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
Other: High intensity aerobic interval training
Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Experimental: Continuous moderate intensity exercise
Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.
Other: Continuous moderate intensity exercise
Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
No Intervention: Non-exercise control group
Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
No Intervention: Healthy control group
Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
- Change in vascular endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ]Brachial flow mediated dilation using ultrasonography
- Change in factors related with endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ]Blood and cellular markers of adiponectin, oxidative stress and inflammation.
- Change in arterial stiffness [ Time Frame: At baseline and after 8 weeks of exercise training ]Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
- Change in cardiac function [ Time Frame: At baseline and after 8 weeks of exercise training ]Left ventricular systolic and diastolic function will be measured using echocardiography.
- Change in maximal oxygen consumption [ Time Frame: At baseline and after 8 weeks of exercise training ]Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883258
|Contact: Demetra D Christou, Ph.Demail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Demetra D Christou, Ph.D 352-294-1715 firstname.lastname@example.org|
|Principal Investigator: Demetra D Christou, Ph.D|
|Principal Investigator:||Demetra D Christou, Ph.D||University of Florida|